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Microchips Initiates Clinical Study
—First Human Demonstration of Responsive, Microreservoir Drug Delivery Technology—
BEDFORD, MA – February 3, 2011 – MicroCHIPS, Inc., a developer of innovative drug delivery systems, is initiating the first clinical study to demonstrate precisely controlled delivery of a peptide from a multi-reservoir, programmable, implant system. The study will assess the pharmacokinetics of long-term parathyroid hormone (hPTH 1-34) delivery in women with osteoporosis.
Parathyroid hormone is a thirty-four amino acid peptide that is currently self-injected daily to increase bone density in women suffering from severe osteoporosis. During MicroCHIPS' first human study, in progress at a site in Denmark, participants will receive a series of precisely timed doses of PTH(1-34) over a period of months, eliminating the need for injections. The drug will be delivered automatically using wireless communication to confirm dose delivery.
"MicroCHIPS' clinical study marks an important milestone in the comprehensive research and development of a new approach to drug delivery," said Robert Langer, ScD, Institute Professor at the Massachusetts Institute of Technology and a MicroCHIPS co-founder. "MicroCHIPS' breakthrough technologies have the ability to transform therapy in numerous disease states using active and responsive drug delivery devices."
MicroCHIPS' systems are designed to achieve more effective regimens and increase control over the dose, timing and location of drug delivery. The reservoir devices can release individual doses of a drug with a range of target pharmacokinetics over an extended in vivo period. Therapy can be delivered on a pre-programmed basis, and the regimen can be modified as a patient's condition changes.
MicroCHIPS' miniaturized systems are adaptable to implants and catheters and can be integrated into external pumps, pens and infusion systems.
"Many of today's drug delivery products can offer only incremental improvements in efficacy and compliance," said Ajit Gill, MicroCHIPS' President and CEO. "MicroCHIPS has developed sophisticated technologies that can function as embedded or standalone delivery devices to create precise dosing regimens. The capabilities are well-suited for the delivery of proteins and peptides where current therapy is complex or cumbersome for patients and their physicians."